Evaluation of Vaccination Coverage and Determinants of Success of the COVID-19 Vaccination Program Among Populations in Very Precarious Situations (PREVAC)

April 5, 2023 updated by: Epicentre

PREVAC: Evaluation of Vaccination Coverage and Determinants of Success of the COVID-19

The main objective of the study is to assess the level of vaccination coverage (VC) against COVID-19 among migrants, homeless and travelling community, according to their living conditions and housing.

The secondary objectives are :

  • to compare the estimated level of vaccination coverage in the different sites and strata (emergency shelters/hotels, camps, workers' hostels, on the street) with the estimated level in the general population of the same territory obtained from the French Health Insurance data (SIVAC).
  • identify the obstacles and leverage of vaccination (i.e. mobile team) according to living conditions and habitat (socio-demographic factors, personal health history, vaccine adherence, local health policies, etc.).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3811

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • Marseille
      • Paris, France
        • Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

migrants, homeless and travelling community

Description

Inclusion Criteria:

  • Adult (18 years and older)
  • People considered as homeless (homeless, living in a camp or squat) or
  • Living in adapted housing (migrant workers' hostel) or
  • Housed in residences of the National System or
  • Housed in a social residence such as a 115 hotel or a social housing centre
  • Freely and voluntarily consenting to participate

Exclusion Criteria:

  • Refusal to participate in the study (non-consent).
  • Language barrier with no in-person or telephone translation available.
  • Impossibility to give free and informed consent (comprehension barrier, cognitive and/or psychiatric and/or addictive disorders, external pressure from family and friends, persons under guardianship, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Shelters Paris/93
Other: Vaccination coverage
proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population
Workers' hostels Paris/93
Other: Vaccination coverage
proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population
travelling community IDF(77/93/95)
Other: Vaccination coverage
proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population
Street/Camps Paris/93
Other: Vaccination coverage
proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population
Covid Homeless and migrants Marseille
Other: Vaccination coverage
proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population
Hostel Paris/93
Other: Vaccination coverage
proportion of people declaring to have received at least one dose of vaccination against COVID-19 among target population

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccination coverage among COVID-19
Time Frame: one month
Assess the proportion of people declaring to have received at least one dose of vaccination against COVID-19 among migrants, homeless and travelling community, according to their living conditions and housing
one month
Identify the most appropriate conditions for the use of vaccination against COVID-19
Time Frame: one month
Promote interventions to encourage the use of COVID-19 vaccination
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epicentre

Collaborators

Agence Regionale de Sante d'Ile de France
Medecins Sans Frontieres, Netherlands
Institut de Recherche en Santé Publique, France
Médecins du Monde
CROIX ROUGE FRANCAISE
OBSERVATOIRE DU SAMU SOCIAL
INTERLOGEMENT 93

Investigators

  • Principal Investigator: Elisabeth POULET, MD, Epicentre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

December 22, 2021

Study Completion (Actual)

December 22, 2021

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

October 7, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A01960-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results will be presented in a report to the Ministry of Health, the Haute Autorité de Santé and the various partners. The main findings of this study could potentially be compared with the findings of other ongoing studies, once they are completed. An abstract of the findings will be submitted for presentation at a scientific conference, and at least one manuscript will be submitted for publication in a peer-reviewed scientific journal.

IPD Sharing Access Criteria

Study partners

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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